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Germany Votes: But What Will Change For Health Care, Medtech Post-Election?

The German Bundestagswahl – the 2017 general election – looks likely to deliver a fourth straight victory for CDU chief Angela Merkel, Europe's most powerful politician and arguably the world's most powerful national female leader. But she will have to invite coalition partners, as in her previous three regimes, which could spell changes for health and the other ministerial portfolios that touch on medtech.

Germany Policy Medical Device

Unlocking Social Media's Potential In Healthcare

As the use of social media continues to rise and become more ubiquitous, researchers are determining how user data can be used in healthcare screening. Medtech Insight explores how social media could be used to predict and manage patient health in the future, including research on its use to improve diabetes management and its potential in mental health assessments.

Digital Health Artificial Intelligence Innovation

Holding Out For Home Hemodialysis: Still-Modest Market Promises Bigger Growth

End-stage renal disease (ESRD) affects 600,000 Americans, striking over 120,000 people a year, and most of these patients require renal replacement therapy, such as hemodialysis. For most, that means a several-hour treatment, three times a week, at a dedicated outpatient center run by a service company like DaVita, Inc., or Fresenius Medical Care. But getting dialyzed at home is another option. Just under 2% of patients do home hemodialysis (HHD) today, but a growing number of companies are betting that this number could increase substantially.

Immunology Commercial Market Intelligence

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Warning Letter Roundup & Recap – Sept. 19, 2017

The only device-related warning letter posted this week by US FDA discusses quality system violations at a Wisconsin maker of organ preservation systems.

Medical Device Regulation Device Warning Letters

Dan Mendelson: Selling The Device Is Not Enough

In the current era, device developers must consider value, costs and bundling of their products to health-care buyers, not just securing fast approval from US FDA and a reimbursement decision from CMS, Avalere President Dan Mendelson writes in this guest column.

Policy Reimbursement Pricing Strategies

US FDA Updates Online Device Export Tracker

The CDRH Export Certification and Tracking System will get a facelift on Sept. 26, with functionality changes to include a mandatory question on a company's most recent FDA inspection.

Medical Device Regulation

Antimicrobial Susceptibility Test-Makers Seek Ways To Shorten FDA Clearance Process

A group of antimicrobial susceptibility test manufacturers are working with US FDA regulators to hasten the clearance process for their products. The agency recent convened a workshop at its Maryland headquarters to help address the issue.

In Vitro Diagnostics Regulation

Australia Sees Surge In Level 3 Audits For Active Implantables

Australian regulators completed more Level 2 compulsory audits of applications to include class III and active implantable medical devices on the Australian Register of Therapeutic Goods in 2016-17.

Australia Approvals

Organ Preservation: FDA Weighs Animal Study Questions For Machine Perfusion Devices

US FDA has drafted a guidance exploring when developers of transplant organ preservation devices should rely on ex vivo versus in vivo animal studies, among other questions.

Regulation Animal Testing

Keep Regulatory Status Quo Post-Brexit, Industry Tells Negotiators

The future regulatory outlook for the UK after the country leaves the EU has not been clear during discussions to date. Now medtech industry associations have spoken out. They warn divergence will hit patient safety and must be avoided.

Policy & Regulation Regulation

Big Week For HPV Dx: FDA Finalizes Guidance, Task Force Supports Solo Testing

An important task force drafted new recommendations supporting human papillomavirus tests as a solo first-line screen for cervical cancer in some women, followed up by a US FDA final guidance document detailing for test-makers how to best ensure assays for the cervical cancer-causing virus are safe and accurate.

Medical Device In Vitro Diagnostics

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Device-Makers Can Forego US FDA Pre-Approval Inspections By Joining New 'Critical-To-Quality' PMA Pilot

Nine manufacturers will be selected to play in the agency's voluntary "Premarket Approval Application Critical to Quality" (PMA CtQ) pilot program. Participants will "discuss device design and manufacturing process quality information with FDA early on" to assist "in its review of the PMA manufacturing section and post-approval inspections," the agency says in a notice set to publish in the Sept. 12 Federal Register.

Quality Control Compliance

US FDA Inspections & FDARA: Will New Law Light The Way For Investigators? Maybe, Experts Say

The FDA Reauthorization Act, enacted last month, includes provisions that aim to improve FDA's inspection process, including putting a stop to arbitrary audit scheduling by the agency – a practice that can cause a facility inspection to drag on for weeks at a time. FDA has until early 2019 to draft a guidance document that lays out how it will ensure a more uniform inspection process that ensures greater parity between foreign and domestic audits. Steps mandated by the new law include notifying firms in advance of records that will be requested during an inspection and specifying a window of time for investigators to conduct the onsite inspections. But industry experts are of two minds as to whether any substantial changes will result from the new law. Also: FDA device center Director Jeff Shuren weighs in.

Quality Control Compliance

World of Change Coming For Device Manufacturers: Developments In FDA And International Inspections

Device companies have an opportunity to leverage several major reforms and initiatives that are getting off the ground related to global facility inspections. But firms must constructively engage with the new programs to reap benefits, say Akin Gump attorneys and former top US FDA officials Nathan Brown and Howard Sklamberg in this guest column.

Quality Control Compliance

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SNAPSHOT: Endoscopic And Pelvic Surgery Devices Market Driven By Innovation, Patient Demand

The global market for endoscopic general and pelvic surgery devices is expected to increase at a CAGR of 5.7%, reaching an estimated $15.8bn in 2021. The major growth driver will be conversion from open to endoscopic surgery and related technological advancements, including better cameras producing brighter, more detailed images and small-diameter devices. The introduction of robotic surgery has been pivotal in expanding the range of procedures, including gastric procedures such as bariatric surgery, which are expected to demonstrate the highest growth during the forecast period (2016-2021), according to a new report by Meddevicetracker.

Surgical Procedures Commercial Medical Device

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US FDA Updates Online Device Export Tracker

The CDRH Export Certification and Tracking System will get a facelift on Sept. 26, with functionality changes to include a mandatory question on a company's most recent FDA inspection.

Medical Device Regulation

Medtronic Launches Advanced Chronic Pain Management System

The next-generation Intellis could strengthen Medtronic’s grip on the spinal cord stimulation market, where it already holds a 30.2% share.

Medical Device Neurology

Pacts In Medtech, July/August 2017

Derived from Strategic Transactions, Informa’s premium source for tracking life-sciences deals, the bimonthly Pacts In Medtech column pulls up notable technology alliances, R&D partnerships and commercial collaborations. In this edition, we highlight industry pacts that were sealed in July and August 2017.

Deals Pacts in Medtech

Unlocking Legalities: False-Claim Standards Continue To Evolve

The finer points of when exactly the US government can collect from a device company for selling it a bill of goods are under reconsideration, even as the fast pace of False Claims Act suits continues, attorneys with law firm Gibson Dunn concluded during a series of recent webinars.

Legal Issues Unlocking Legalities

Philly Pelvic Mesh Trial Ends In Largest Verdict Against Ethicon

A Philadelphia jury awarded $57m to a woman who says she was injured by Ethicon pelvic mesh products in the fifth judgement against the company in the city’s Court of Common Pleas.

Medical Device Gynecology & Urology

Abbott Pulls Absorb Stent Off The Market, Citing Low Sales

Abbott is giving up on selling its first-generation biosorbable coronary stent, which failed to match the performance of contemporary metallic drug-eluting stents in clinical trials. The company says it will continue working on the next-generation biosorbable stents and continue the ongoing trials of Absorb GT1 BVS.

Commercial Cardiovascular

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OUS Approvals Analysis: Medtronic, MicroPort Lead August's Line-Up Of International Approvals

There were 16 CE marks and seven medical device approvals in regions outside of the US and EU in August, according to Medtech Insight's Approvals Tracker. Although 23 approvals in a month is below average for the 2017 OUS tracker, it's more than appeared in August 2016 or 2015, and keeps 2017 on track for 351 approvals from outside the US.

Approvals Innovation Research & Development

Latest From Research & Development

Leveraging mHealth Data For Product Development: FDA-Supported Action Plan Released

Mobile health devices including wearable consumer products have the potential to collect a lot of medical information that can be useful for product development and tracking. A new action plan from US FDA, industry and other key players outlines ways to harness and use that data to bring better products to market more quickly.

Digital Health Clinical Trials

First Anti-Addiction App Approved In The US

Pear Therapeutics' reSET mobile application to treat substance addictions in combination with outpatient therapy programs has been approved by US FDA. The agency approved the software after a multi-site clinical trial showed patients were significantly more successful remaining abstinent after using the app.

Regulation Approvals

US Approvals Analysis: Abbott Leads Another Strong Month For Novel Approvals

Abbott Laboratories accounted for two of five original PMA approvals recorded by US FDA in August. That update and more from Medtech Insight's Approvals Tracker.

Approvals Innovation

UK Industry Targets Best Outcome From Life Science Strategy

The UK medical device industry wasted no time in analyzing the newly-issued Life Sciences Strategy, and found some good elements, but also areas where there is room for improvement.

United Kingdom Market Access

J&J's Ethicon Calls For Game-Changing Holistic Approach To Obesity Care

At this year's 22nd World Congress of the International Federation for the Surgery of Obesity and Metabolic Diseases, Johnson & Johnson subsidiary Ethicon launched a new initiative to significantly alter the way obesity is viewed and to change the patient care pathway for the better.

Metabolic Surgery

ESC 2017: News Flutter With AFib Data

Atrial fibrillation is always a hot topic at cardiology conferences and this year's European Society of Cardiology Congress in Barcelona was no exception. The meeting highlighted data from a spate of key clinical studies providing more insight into this heart condition, including the CASTLE-AF and CAPTAF studies, which further affirmed the benefits of catheter ablation. Outcomes were also reported from REHEARSE-AF and AFFIRM.

Cardiology Innovation